510(k) K160960
K160960 is an FDA 510(k) premarket notification submitted by Endogastric Solutions, Inc. for the device "EsophyX® Z Device with SerosaFuse Fasteners and Accessories". The FDA issued a decision of Substantially Equivalent on May 1, 2016. The device falls under product code ODE (Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)), a Class II device regulated under 21 CFR 876.1500. Endogastric Solutions, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 1, 2016
- Date Received
- April 5, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant.